CHILD DEVELOPMENT IN RELATION TO EARLY OTITIS MEDIA

描述：（改编自申请人的摘要）本申请是一个 第二次修订本最初于1988年9月提交， 1989年9月 本研究的目的是确定：（1） 渗出性中耳炎（OME）是否发生在常见的水平， 在生命的头三年的频率和持续时间， 言语、语言、认知和心理社会发展障碍; 和（2）快速鼓室切开置管术（TTP）是否有效， 预防或减轻损伤。 提出了两个零假设： (1)在第一次OME的累积持续时间较短的儿童 三年的生活将达到某些指定的测试分数在年龄 3到7岁，这并不比孩子的分数更有利 OME累积持续时间更长（在规定的上限内） 在生命的前三年;（2）OME儿童在 前三年的生活谁是管理与鼓膜管放置 (TTP)随机分为两组，分别接受：（a）提示TTP; 或（B）延迟TTP将显示某些指定测试的分数， 两个TTP组之间无显著差异。 总共有5，338名不到两个月大的健康婴儿将被 参加了一项为期21个月的前瞻性研究。 中耳状况 将在生命的头两年每月监测一次， 在第二年和其后每季度通过鼓室压测定法 和气动耳镜检查 听力水平将每月监测一次， 患有持续性渗出性中耳炎的儿童。 的儿童 在前三年内符合持续OME的特定标准 在征得父母同意的情况下， 如果OME仍然存在，则立即（早期TTP）或在规定的时间段后 存在（晚期TTP）。 发展成果将在所有 受试者在2个月，1岁和2岁时通过标准化 问卷调查 言语、语言、认知和心理社会发展 将在所有早期TTP和晚期TTP受试者中以及 其余受试者在3岁、4岁、5岁、6岁和7岁时使用标准化测试。

DESCRIPTION: (Adapted From The Applicant's Abstract) This application is a second revision originally submitted on September, 1988 and resubmitted on September, 1989. The objectives of this study are to determine: (1) whether otitis media with effusion (OME) occurring at common levels of frequency and duration during the first three years of life causes lasting impairments in speech, language, cognitive and psychosocial development; and (2) whether prompt tympanotomy-tube placement (TTP) is efficacious in preventing or lessening the impairments. Two null hypotheses are proposed: (1) that children with lesser cumulative durations of OME during the first three years of life will achieve scores on certain designated tests at ages 3 through 7 years which are no more favorable than the scores of children with greater cumulative durations of OME (within specified upper limits) during the first three years of life; (2) that children with OME during the first three years of life who are managed with tympanotomy-tube placement (TTP), if divided randomly into two groups which receive: (a) prompt TTP; or (b) delayed TTP will show scores on certain designated tests which are not significantly different between the two TTP groups. A total of 5,338 healthy infants less than two months of age will be enrolled in a prospective study over a 21-month period. Middle ear status will be monitored monthly during the first two years of life, bimonthly during the second year and quarterly thereafter by means of tympanometry and pneumatic otoscopy. Hearing levels will be monitored monthly in children who develop persistent otitis media with effusion. Children who meet specific criteria for persistent OME during the first three years of life will, subject to parental consent, be randomly assigned to receive TTP either promptly (early TTP) or after a defined period if OME is still present (late TTP). Developmental outcomes will be assessed in all subjects at ages 2 months, 1 year and 2 years through standardized questionnaires. Speech, language, cognitive and psychosocial development will be assessed in all early TTP and late TTP subjects and in a sample of remaining subjects at ages 3, 4, 5, 6 and 7 years using standardized tests.